Trial Outcomes & Findings for Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study (NCT NCT04084314)
NCT ID: NCT04084314
Last Updated: 2024-10-09
Results Overview
This outcome measure was calculated dividing the number of adverse events (AEs) by the total patient exposure time and standardizing it per 100 patient-years. Exact Pearson-Clopper confidence intervals for single proportions were calculated to evaluate the precision of the estimated parameter.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
701 participants
Primary outcome timeframe
Up to 128 weeks
Results posted on
2024-10-09
Participant Flow
Participants took part in 79 investigative sites in Germany.
The screening period began once patients had signed the study informed consent. The Screening Epoch had a duration of 2 weeks. Eligible patients came from study CAMG334ADE01 (NCT03828539).
Participant milestones
| Measure |
Erenumab
Erenumab dose could be adjusted from 70 mg to 140 mg or vice versa at the discretion of the physician at any scheduled study visit.
|
|---|---|
|
Overall Study
STARTED
|
701
|
|
Overall Study
COMPLETED
|
534
|
|
Overall Study
NOT COMPLETED
|
167
|
Reasons for withdrawal
| Measure |
Erenumab
Erenumab dose could be adjusted from 70 mg to 140 mg or vice versa at the discretion of the physician at any scheduled study visit.
|
|---|---|
|
Overall Study
Subject/guardian decision
|
91
|
|
Overall Study
Adverse Event
|
24
|
|
Overall Study
Lost to Follow-up
|
19
|
|
Overall Study
New therapy for study indication
|
9
|
|
Overall Study
Pregnancy
|
9
|
|
Overall Study
Withdrawal of informed consent
|
8
|
|
Overall Study
Physician Decision
|
4
|
|
Overall Study
Protocol Deviation
|
3
|
Baseline Characteristics
Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study
Baseline characteristics by cohort
| Measure |
Erenumab
n=701 Participants
Erenumab dose could be adjusted from 70 mg to 140 mg or vice versa at the discretion of the physician at any scheduled study visit.
|
|---|---|
|
Age, Continuous
|
41.8 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
608 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
93 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
695 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 128 weeksPopulation: Safety set (SAF) defined as all patients who received at least one dose of study treatment in the Open-label Treatment Epoch of this study.
This outcome measure was calculated dividing the number of adverse events (AEs) by the total patient exposure time and standardizing it per 100 patient-years. Exact Pearson-Clopper confidence intervals for single proportions were calculated to evaluate the precision of the estimated parameter.
Outcome measures
| Measure |
Erenumab
n=701 Participants
Erenumab dose could be adjusted from 70 mg to 140 mg or vice versa at the discretion of the physician at any scheduled study visit.
|
|---|---|
|
Exposure Adjusted Incidence Rate of AE During Open-label Treatment Epoch Per 100 Subject Years
|
101.71 number of AEs per 100 patient-years
Interval 92.28 to 111.14
|
SECONDARY outcome
Timeframe: Up to 128 weeksPopulation: Safety set (SAF) defined as all patients who received at least one dose of study treatment in the Open-label Treatment Epoch of this study.
Participants discontinuing the Open-label Treatment Epoch due to adverse events (AEs) to evaluate the long-term tolerability of erenumab in patients with episodic migraine or chronic migraine.
Outcome measures
| Measure |
Erenumab
n=701 Participants
Erenumab dose could be adjusted from 70 mg to 140 mg or vice versa at the discretion of the physician at any scheduled study visit.
|
|---|---|
|
Proportion of Patients Discontinuing Open-label Treatment Epoch Due to AE
|
29 Participants
|
SECONDARY outcome
Timeframe: Up to 128 weeksPopulation: Safety set (SAF) defined as all patients who received at least one dose of study treatment in the Open-label Treatment Epoch of this study.
Participants discontinuing the Open-label Treatment Epoch due to non-AE reasons to evaluate the long-term tolerability of erenumab in patients with episodic migraine or chronic migraine.
Outcome measures
| Measure |
Erenumab
n=701 Participants
Erenumab dose could be adjusted from 70 mg to 140 mg or vice versa at the discretion of the physician at any scheduled study visit.
|
|---|---|
|
Proportion of Patients Discontinuing Open-label Treatment Epoch Due to Non-AE Reasons
|
126 Participants
|
Adverse Events
Erenumab
Serious events: 86 serious events
Other events: 514 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Erenumab
n=701 participants at risk
Erenumab dose could be adjusted from 70 mg to 140 mg or vice versa at the discretion of the physician at any scheduled study visit.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Cardiac disorders
Myocardial infarction
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Cardiac disorders
Tachycardia
|
0.29%
2/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Congenital, familial and genetic disorders
Macrocornea
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Ear and labyrinth disorders
Vertigo
|
0.29%
2/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Ear and labyrinth disorders
Vestibular paroxysmia
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Endocrine disorders
Goitre
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Eye disorders
Cataract
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Eye disorders
Lens dislocation
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Gastrointestinal disorders
Anal fistula
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Gastrointestinal disorders
Enteritis
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Gastrointestinal disorders
Eosinophilic oesophagitis
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Gastrointestinal disorders
Ileus
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Gastrointestinal disorders
Internal hernia
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Gastrointestinal disorders
Intestinal stenosis
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Gastrointestinal disorders
Volvulus
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
General disorders
Asthenia
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
General disorders
Capsular contracture associated with breast implant
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
General disorders
Pain
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
General disorders
Pyrexia
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.29%
2/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Immune system disorders
Hypersensitivity
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Infections and infestations
Appendicitis
|
0.57%
4/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Infections and infestations
Appendicitis perforated
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Infections and infestations
Bartholinitis
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Infections and infestations
COVID-19
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Infections and infestations
Gastroenteritis
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Infections and infestations
Herpes zoster
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Infections and infestations
Infection
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Infections and infestations
Nephritis bacterial
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Infections and infestations
Pneumonia viral
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Infections and infestations
Root canal infection
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Infections and infestations
Tonsillitis
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Infections and infestations
Urinary tract infection
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Infections and infestations
Vestibular neuronitis
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.29%
2/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Injury, poisoning and procedural complications
Bursa injury
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Injury, poisoning and procedural complications
Shoulder fracture
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.57%
4/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.00%
7/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Musculoskeletal and connective tissue disorders
Vertebral osteophyte
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.29%
2/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Nervous system disorders
Cerebellar atrophy
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Nervous system disorders
Headache
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Nervous system disorders
Hypoaesthesia
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Nervous system disorders
Migraine
|
0.29%
2/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Nervous system disorders
Multiple sclerosis
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Nervous system disorders
Nerve compression
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Nervous system disorders
Presyncope
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Nervous system disorders
Syncope
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.29%
2/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Pregnancy, puerperium and perinatal conditions
Retroplacental haematoma
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Psychiatric disorders
Depression
|
0.71%
5/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Psychiatric disorders
Depression suicidal
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Psychiatric disorders
Major depression
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Psychiatric disorders
Panic attack
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Psychiatric disorders
Suicide attempt
|
0.29%
2/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Renal and urinary disorders
Renal colic
|
0.29%
2/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Reproductive system and breast disorders
Endometriosis
|
0.29%
2/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Vascular disorders
Circulatory collapse
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Vascular disorders
Hypertension
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Vascular disorders
Raynaud's phenomenon
|
0.14%
1/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
Other adverse events
| Measure |
Erenumab
n=701 participants at risk
Erenumab dose could be adjusted from 70 mg to 140 mg or vice versa at the discretion of the physician at any scheduled study visit.
|
|---|---|
|
Ear and labyrinth disorders
Vertigo
|
3.6%
25/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.1%
15/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Gastrointestinal disorders
Constipation
|
14.7%
103/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
17/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Gastrointestinal disorders
Nausea
|
4.9%
34/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
General disorders
Chills
|
2.9%
20/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
General disorders
Fatigue
|
8.7%
61/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
General disorders
Pyrexia
|
2.9%
20/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Infections and infestations
COVID-19
|
34.5%
242/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Infections and infestations
Cystitis
|
3.3%
23/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Infections and infestations
Nasopharyngitis
|
19.1%
134/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Infections and infestations
Tonsillitis
|
2.6%
18/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Infections and infestations
Urinary tract infection
|
2.6%
18/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
6.1%
43/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Injury, poisoning and procedural complications
Post vaccination fever
|
2.1%
15/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.3%
16/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.7%
33/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.0%
42/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.1%
15/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.4%
17/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.1%
29/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Nervous system disorders
Dizziness
|
3.4%
24/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Nervous system disorders
Headache
|
6.0%
42/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Nervous system disorders
Migraine
|
6.1%
43/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Psychiatric disorders
Depression
|
5.6%
39/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
18/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.9%
20/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.0%
28/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.6%
18/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
|
Vascular disorders
Hypertension
|
6.6%
46/701 • From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. Novartis does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER