Time Frame |
Adverse events were collected from treatment initiation until 30 days following the last administration of study drug or study discontinuation on 31 August 2015 (up to approximately 4 years).
|
Adverse Event Reporting Description |
Safety population: All participants who received any amount of planned study treatment, according to treatment actually received. Data for participants in the Treatment of Physicians Choice (TPC) arm who switched treatment to receive trastuzumab emtansine (TE) following disease progression on TPC are presented separately. Median treatment duration of trastuzumab emtansine: 5.2 months (range 0.03-40.7),TPC: 2.7 months (range 0.03-31.0) and TE - Post TPC Treatment Switch: 4.5 months (range 1-43).
|
|
Arm/Group Title
|
Trastuzumab Emtansine
|
Treatment of Physician's Choice (TPC)
|
Trastuzumab Emtansine - Post TPC Treatment Switch
|
Arm/Group Description |
Trastuzumab emtansine 3.6 mg/kg int...
|
Treatment of physician's choice unt...
|
Participants, who switched treatmen...
|
Arm/Group Description |
Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
|
Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
|
Participants, who switched treatment in the Treatment of Physician's Choice arm to trastuzumab emtansine, were administered trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
|
|
|
Trastuzumab Emtansine
|
Treatment of Physician's Choice (TPC)
|
Trastuzumab Emtansine - Post TPC Treatment Switch
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
--/-- |
--/-- |
--/-- |
|
|
Trastuzumab Emtansine
|
Treatment of Physician's Choice (TPC)
|
Trastuzumab Emtansine - Post TPC Treatment Switch
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
102/403 (25.31%) |
41/184 (22.28%) |
19/94 (20.21%) |
Blood and lymphatic system disorders |
|
|
|
Anaemia |
1/403 (0.25%) |
2/184 (1.09%) |
1/94 (1.06%) |
Febrile neutropenia |
1/403 (0.25%) |
7/184 (3.80%) |
0/94 (0.00%) |
Granulocytopenia |
0/403 (0.00%) |
1/184 (0.54%) |
0/94 (0.00%) |
Neutropenia |
1/403 (0.25%) |
2/184 (1.09%) |
0/94 (0.00%) |
Thrombocytopenia |
1/403 (0.25%) |
1/184 (0.54%) |
0/94 (0.00%) |
Cardiac disorders |
|
|
|
Cardiac failure |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Ear and labyrinth disorders |
|
|
|
Vertigo |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Endocrine disorders |
|
|
|
Hypercalcaemia of malignancy |
0/403 (0.00%) |
1/184 (0.54%) |
0/94 (0.00%) |
Eye disorders |
|
|
|
Vision blurred |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Gastrointestinal disorders |
|
|
|
Abdominal discomfort |
0/403 (0.00%) |
1/184 (0.54%) |
0/94 (0.00%) |
Abdominal pain |
4/403 (0.99%) |
3/184 (1.63%) |
1/94 (1.06%) |
Abdominal pain upper |
0/403 (0.00%) |
1/184 (0.54%) |
0/94 (0.00%) |
Abdominal wall haematoma |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Colitis |
2/403 (0.50%) |
0/184 (0.00%) |
0/94 (0.00%) |
Diarrhoea |
2/403 (0.50%) |
1/184 (0.54%) |
0/94 (0.00%) |
Gastric haemorrhage |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Ileus |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Nausea |
0/403 (0.00%) |
2/184 (1.09%) |
0/94 (0.00%) |
Obstruction gastric |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Pancreatitis |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Proctitis Haemorrhagic |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Small intestinal obstruction |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Upper gastrointestinal haemorrhage |
0/403 (0.00%) |
1/184 (0.54%) |
1/94 (1.06%) |
Vomiting |
2/403 (0.50%) |
2/184 (1.09%) |
0/94 (0.00%) |
General disorders |
|
|
|
Adverse drug reaction |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Asthenia |
3/403 (0.74%) |
0/184 (0.00%) |
0/94 (0.00%) |
Death |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Device occlusion |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Fatigue |
1/403 (0.25%) |
1/184 (0.54%) |
0/94 (0.00%) |
General physical health deterioration |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Malaise |
2/403 (0.50%) |
0/184 (0.00%) |
0/94 (0.00%) |
Non-cardiac chest pain |
0/403 (0.00%) |
1/184 (0.54%) |
0/94 (0.00%) |
Oedema peripheral |
2/403 (0.50%) |
2/184 (1.09%) |
0/94 (0.00%) |
Pain |
0/403 (0.00%) |
1/184 (0.54%) |
0/94 (0.00%) |
Pyrexia |
7/403 (1.74%) |
2/184 (1.09%) |
1/94 (1.06%) |
Vessel puncture site haemorrhage |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Hepatobiliary disorders |
|
|
|
Bile duct obstruction |
1/403 (0.25%) |
1/184 (0.54%) |
0/94 (0.00%) |
Cholangitis |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Cholecystitis |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Nodular regenerative hyperplasia |
3/403 (0.74%) |
0/184 (0.00%) |
0/94 (0.00%) |
Hepatotoxicity |
0/403 (0.00%) |
0/184 (0.00%) |
1/94 (1.06%) |
Immune system disorders |
|
|
|
Drug hypersensitivity |
0/403 (0.00%) |
1/184 (0.54%) |
0/94 (0.00%) |
Hypersensitivity |
1/403 (0.25%) |
0/184 (0.00%) |
1/94 (1.06%) |
Infections and infestations |
|
|
|
Appendicitis |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Bronchopneumonia |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Cellulitis |
2/403 (0.50%) |
4/184 (2.17%) |
1/94 (1.06%) |
Clostridium bacteraemia |
0/403 (0.00%) |
1/184 (0.54%) |
0/94 (0.00%) |
Device related infection |
1/403 (0.25%) |
1/184 (0.54%) |
0/94 (0.00%) |
Device related sepsis |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Gastroenteritis |
2/403 (0.50%) |
0/184 (0.00%) |
0/94 (0.00%) |
Infected fistula |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Infection |
2/403 (0.50%) |
0/184 (0.00%) |
0/94 (0.00%) |
Infectious colitis |
0/403 (0.00%) |
1/184 (0.54%) |
0/94 (0.00%) |
Lung infection |
1/403 (0.25%) |
0/184 (0.00%) |
1/94 (1.06%) |
Lymphangitis |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Mastitis |
0/403 (0.00%) |
1/184 (0.54%) |
0/94 (0.00%) |
Neutropenic sepsis |
0/403 (0.00%) |
1/184 (0.54%) |
0/94 (0.00%) |
Pharyngotonsillitis |
0/403 (0.00%) |
1/184 (0.54%) |
0/94 (0.00%) |
Pneumonia |
5/403 (1.24%) |
0/184 (0.00%) |
1/94 (1.06%) |
Postoperative wound infection |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Sepsis |
3/403 (0.74%) |
0/184 (0.00%) |
0/94 (0.00%) |
Sinusitis |
1/403 (0.25%) |
1/184 (0.54%) |
0/94 (0.00%) |
Tracheitis |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Upper respiratory tract infection |
2/403 (0.50%) |
0/184 (0.00%) |
0/94 (0.00%) |
Urinary tract infection |
4/403 (0.99%) |
0/184 (0.00%) |
0/94 (0.00%) |
Urosepsis |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Viral upper respiratory tract infection |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Wound infection |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Abdominal infection |
0/403 (0.00%) |
0/184 (0.00%) |
1/94 (1.06%) |
Abscess |
0/403 (0.00%) |
0/184 (0.00%) |
1/94 (1.06%) |
Biliary tract infection |
0/403 (0.00%) |
0/184 (0.00%) |
1/94 (1.06%) |
Injury, poisoning and procedural complications |
|
|
|
Fall |
2/403 (0.50%) |
0/184 (0.00%) |
0/94 (0.00%) |
Femoral neck fracture |
2/403 (0.50%) |
0/184 (0.00%) |
0/94 (0.00%) |
Femur fracture |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Infusion related reaction |
1/403 (0.25%) |
1/184 (0.54%) |
0/94 (0.00%) |
Sternal fracture |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Subdural haematoma |
2/403 (0.50%) |
0/184 (0.00%) |
0/94 (0.00%) |
Subdural haemorrhage |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Thoracic vertebral fracture |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Traumatic intracranial haemorrhage |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Wound decomposition |
0/403 (0.00%) |
1/184 (0.54%) |
0/94 (0.00%) |
Wound haemorrhage |
1/403 (0.25%) |
1/184 (0.54%) |
0/94 (0.00%) |
Toxicity to various agents |
0/403 (0.00%) |
0/184 (0.00%) |
1/94 (1.06%) |
Upper limb fracture |
0/403 (0.00%) |
0/184 (0.00%) |
1/94 (1.06%) |
Investigations |
|
|
|
Transaminases increased |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
White blood cell count decreased |
0/403 (0.00%) |
1/184 (0.54%) |
0/94 (0.00%) |
Metabolism and nutrition disorders |
|
|
|
Decreased appetite |
1/403 (0.25%) |
0/184 (0.00%) |
1/94 (1.06%) |
Dehydration |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Hypercalcaemia |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Hyperglycaemia |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Hypokalaemia |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Hyponatraemia |
4/403 (0.99%) |
0/184 (0.00%) |
0/94 (0.00%) |
Hypophagia |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Malnutrition |
0/403 (0.00%) |
1/184 (0.54%) |
0/94 (0.00%) |
Musculoskeletal and connective tissue disorders |
|
|
|
Arthralgia |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Back pain |
2/403 (0.50%) |
0/184 (0.00%) |
0/94 (0.00%) |
Bone pain |
0/403 (0.00%) |
1/184 (0.54%) |
0/94 (0.00%) |
Muscle haemorrhage |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Musculoskeletal chest pain |
1/403 (0.25%) |
1/184 (0.54%) |
0/94 (0.00%) |
Myalgia |
0/403 (0.00%) |
1/184 (0.54%) |
0/94 (0.00%) |
Spinal pain |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Muscular weakness |
0/403 (0.00%) |
0/184 (0.00%) |
1/94 (1.06%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
Rectal adenocarcinoma |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Tumour haemorrhage |
2/403 (0.50%) |
0/184 (0.00%) |
0/94 (0.00%) |
Tumor pain |
0/403 (0.00%) |
1/184 (0.54%) |
0/94 (0.00%) |
Tumour necrosis |
0/403 (0.00%) |
0/184 (0.00%) |
1/94 (1.06%) |
Nervous system disorders |
|
|
|
Ataxia |
1/403 (0.25%) |
1/184 (0.54%) |
0/94 (0.00%) |
Brain oedema |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Cerebral haematoma |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Cerebral haemorrhage |
2/403 (0.50%) |
0/184 (0.00%) |
0/94 (0.00%) |
Cognitive disorder |
0/403 (0.00%) |
1/184 (0.54%) |
0/94 (0.00%) |
Depressed level of consciousness |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Dizziness |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Haemorrhage intracranial |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Hepatic encephalopathy |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Loss of consciousness |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Paraesthesia |
0/403 (0.00%) |
1/184 (0.54%) |
0/94 (0.00%) |
Paraparesis |
0/403 (0.00%) |
1/184 (0.54%) |
0/94 (0.00%) |
Seizure |
5/403 (1.24%) |
0/184 (0.00%) |
1/94 (1.06%) |
Somnolence |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Subarachnoid haemorrhage |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Transient ischaemic attack |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Visual field defect |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Epilepsy |
0/403 (0.00%) |
0/184 (0.00%) |
1/94 (1.06%) |
Hemiplegia |
0/403 (0.00%) |
0/184 (0.00%) |
1/94 (1.06%) |
Psychiatric disorders |
|
|
|
Confusional state |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Renal and urinary disorders |
|
|
|
Haematuria |
1/403 (0.25%) |
1/184 (0.54%) |
0/94 (0.00%) |
Reproductive system and breast disorders |
|
|
|
Vaginal haemorrhage |
2/403 (0.50%) |
0/184 (0.00%) |
0/94 (0.00%) |
Respiratory, thoracic and mediastinal disorders |
|
|
|
Dyspnoea |
6/403 (1.49%) |
5/184 (2.72%) |
2/94 (2.13%) |
Epistaxis |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Haemoptysis |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Non-cardiogenic pulmonary oedema |
0/403 (0.00%) |
1/184 (0.54%) |
0/94 (0.00%) |
Obliterative bronchiolitis |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Pleural effusion |
3/403 (0.74%) |
2/184 (1.09%) |
0/94 (0.00%) |
Pleuritic pain |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Pneumonia aspiration |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Pneumonitis |
2/403 (0.50%) |
1/184 (0.54%) |
0/94 (0.00%) |
Pneumothorax |
1/403 (0.25%) |
1/184 (0.54%) |
0/94 (0.00%) |
Pulmonary embolism |
1/403 (0.25%) |
2/184 (1.09%) |
1/94 (1.06%) |
Respiratory failure |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Pulmonary Fibrosis |
0/403 (0.00%) |
0/184 (0.00%) |
1/94 (1.06%) |
Vascular disorders |
|
|
|
Deep vein thrombosis |
2/403 (0.50%) |
0/184 (0.00%) |
0/94 (0.00%) |
Embolism |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Embolism venous |
0/403 (0.00%) |
1/184 (0.54%) |
0/94 (0.00%) |
Hypertensive crisis |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Hypotension |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Lymphoedema |
0/403 (0.00%) |
1/184 (0.54%) |
1/94 (1.06%) |
Superior vena cava syndrome |
1/403 (0.25%) |
0/184 (0.00%) |
0/94 (0.00%) |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA (16.0)
|
|
Frequency Threshold for Reporting Other Adverse Events
|
5%
|
|
Trastuzumab Emtansine
|
Treatment of Physician's Choice (TPC)
|
Trastuzumab Emtansine - Post TPC Treatment Switch
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
371/403 (92.06%) |
148/184 (80.43%) |
74/94 (78.72%) |
Blood and lymphatic system disorders |
|
|
|
Anaemia |
45/403 (11.17%) |
19/184 (10.33%) |
7/94 (7.45%) |
Leukopenia |
9/403 (2.23%) |
11/184 (5.98%) |
0/94 (0.00%) |
Neutropenia |
30/403 (7.44%) |
39/184 (21.20%) |
5/94 (5.32%) |
Thrombocytopenia |
81/403 (20.10%) |
6/184 (3.26%) |
17/94 (18.09%) |
Eye disorders |
|
|
|
Lacrimation increased |
0/403 (0.00%) |
0/184 (0.00%) |
5/94 (5.32%) |
Gastrointestinal disorders |
|
|
|
Abdominal pain |
27/403 (6.70%) |
20/184 (10.87%) |
9/94 (9.57%) |
Constipation |
90/403 (22.33%) |
32/184 (17.39%) |
7/94 (7.45%) |
Diarrhoea |
52/403 (12.90%) |
40/184 (21.74%) |
10/94 (10.64%) |
Dry mouth |
51/403 (12.66%) |
2/184 (1.09%) |
9/94 (9.57%) |
Dyspepsia |
21/403 (5.21%) |
12/184 (6.52%) |
0/94 (0.00%) |
Gingival bleeding |
21/403 (5.21%) |
0/184 (0.00%) |
0/94 (0.00%) |
Nausea |
144/403 (35.73%) |
40/184 (21.74%) |
16/94 (17.02%) |
Stomatitis |
13/403 (3.23%) |
11/184 (5.98%) |
0/94 (0.00%) |
Vomiting |
77/403 (19.11%) |
16/184 (8.70%) |
10/94 (10.64%) |
Abdominal pain upper |
0/403 (0.00%) |
0/184 (0.00%) |
7/94 (7.45%) |
General disorders |
|
|
|
Asthenia |
76/403 (18.86%) |
33/184 (17.93%) |
15/94 (15.96%) |
Chills |
21/403 (5.21%) |
4/184 (2.17%) |
0/94 (0.00%) |
Fatigue |
123/403 (30.52%) |
48/184 (26.09%) |
10/94 (10.64%) |
Influenza like illness |
21/403 (5.21%) |
2/184 (1.09%) |
0/94 (0.00%) |
Mucosal inflammation |
17/403 (4.22%) |
10/184 (5.43%) |
7/94 (7.45%) |
Oedema peripheral |
26/403 (6.45%) |
11/184 (5.98%) |
0/94 (0.00%) |
Pyrexia |
77/403 (19.11%) |
22/184 (11.96%) |
14/94 (14.89%) |
Pain |
0/403 (0.00%) |
0/184 (0.00%) |
5/94 (5.32%) |
Infections and infestations |
|
|
|
Nasopharyngitis |
35/403 (8.68%) |
12/184 (6.52%) |
6/94 (6.38%) |
Upper respiratory tract infection |
35/403 (8.68%) |
8/184 (4.35%) |
8/94 (8.51%) |
Urinary tract infection |
26/403 (6.45%) |
7/184 (3.80%) |
9/94 (9.57%) |
Sinusitis |
0/403 (0.00%) |
0/184 (0.00%) |
5/94 (5.32%) |
Investigations |
|
|
|
Alanine aminotransferase increased |
38/403 (9.43%) |
10/184 (5.43%) |
7/94 (7.45%) |
Aspartate aminotransferase increased |
51/403 (12.66%) |
13/184 (7.07%) |
13/94 (13.83%) |
Blood alkaline phosphatase increased |
21/403 (5.21%) |
5/184 (2.72%) |
7/94 (7.45%) |
Blood bilirubin increased |
38/403 (9.43%) |
2/184 (1.09%) |
5/94 (5.32%) |
Ejection fraction decreased |
11/403 (2.73%) |
12/184 (6.52%) |
0/94 (0.00%) |
Metabolism and nutrition disorders |
|
|
|
Decreased appetite |
66/403 (16.38%) |
25/184 (13.59%) |
15/94 (15.96%) |
Hypokalaemia |
30/403 (7.44%) |
4/184 (2.17%) |
6/94 (6.38%) |
Hyperglycaemia |
0/403 (0.00%) |
0/184 (0.00%) |
5/94 (5.32%) |
Musculoskeletal and connective tissue disorders |
|
|
|
Arthralgia |
60/403 (14.89%) |
8/184 (4.35%) |
7/94 (7.45%) |
Back pain |
35/403 (8.68%) |
13/184 (7.07%) |
6/94 (6.38%) |
Bone pain |
22/403 (5.46%) |
7/184 (3.80%) |
0/94 (0.00%) |
Muscle spasms |
26/403 (6.45%) |
9/184 (4.89%) |
0/94 (0.00%) |
Musculoskeletal pain |
18/403 (4.47%) |
10/184 (5.43%) |
7/94 (7.45%) |
Myalgia |
47/403 (11.66%) |
14/184 (7.61%) |
6/94 (6.38%) |
Pain in extremity |
44/403 (10.92%) |
9/184 (4.89%) |
0/94 (0.00%) |
Nervous system disorders |
|
|
|
Dizziness |
31/403 (7.69%) |
6/184 (3.26%) |
6/94 (6.38%) |
Headache |
100/403 (24.81%) |
22/184 (11.96%) |
16/94 (17.02%) |
Neuropathy peripheral |
20/403 (4.96%) |
10/184 (5.43%) |
7/94 (7.45%) |
Paraesthesia |
28/403 (6.95%) |
11/184 (5.98%) |
9/94 (9.57%) |
Psychiatric disorders |
|
|
|
Insomnia |
35/403 (8.68%) |
6/184 (3.26%) |
8/94 (8.51%) |
Respiratory, thoracic and mediastinal disorders |
|
|
|
Cough |
76/403 (18.86%) |
24/184 (13.04%) |
12/94 (12.77%) |
Dyspnoea |
42/403 (10.42%) |
21/184 (11.41%) |
6/94 (6.38%) |
Epistaxis |
67/403 (16.63%) |
7/184 (3.80%) |
12/94 (12.77%) |
Skin and subcutaneous tissue disorders |
|
|
|
Alopecia |
9/403 (2.23%) |
20/184 (10.87%) |
0/94 (0.00%) |
Pruritus |
23/403 (5.71%) |
17/184 (9.24%) |
0/94 (0.00%) |
Rash |
27/403 (6.70%) |
19/184 (10.33%) |
0/94 (0.00%) |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA (16.0)
|