Trial Outcomes & Findings for Study Comparing Daclatasvir (BMS-790052) With Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Virus Infection (NCT NCT01492426)
NCT ID: NCT01492426
Last Updated: 2016-06-03
Results Overview
SVR12 was defined as hepatitis C virus RNA levels to be lower than the limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up Week 12.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
605 participants
Primary outcome timeframe
Week 12 (Follow-up period)
Results posted on
2016-06-03
Participant Flow
A total of 793 participants were recruited at 90 sites in 15 countries.
Of the 793 participants, 605 were randomized to treatment. A total of 191 enrolled subjects did not enter the treatment period as they no longer met study entry criteria and a 602 participants were received treatment.
Participant milestones
| Measure |
Daclatasvir + PEG-IFN Alpha-2a + Ribavirin
Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
|
Telaprevir + PEG-IFN Alpha-2a + Ribavirin
Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000-1200 mg per day was administered twice daily with food.
|
|---|---|---|
|
Treatment
STARTED
|
402
|
200
|
|
Treatment
COMPLETED
|
319
|
160
|
|
Treatment
NOT COMPLETED
|
83
|
40
|
|
Follow-Up
STARTED
|
384
|
191
|
|
Follow-Up
COMPLETED
|
359
|
181
|
|
Follow-Up
NOT COMPLETED
|
25
|
10
|
Reasons for withdrawal
| Measure |
Daclatasvir + PEG-IFN Alpha-2a + Ribavirin
Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
|
Telaprevir + PEG-IFN Alpha-2a + Ribavirin
Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000-1200 mg per day was administered twice daily with food.
|
|---|---|---|
|
Treatment
Death
|
0
|
1
|
|
Treatment
Other
|
1
|
0
|
|
Treatment
Adverse Event
|
25
|
25
|
|
Treatment
Lack of Efficacy
|
38
|
5
|
|
Treatment
Participant withdrew consent
|
1
|
2
|
|
Treatment
Poor compliance/noncompliance
|
1
|
0
|
|
Treatment
Subject requested discontinue study drug
|
7
|
3
|
|
Treatment
Lost to Follow-up
|
9
|
4
|
|
Treatment
Participant does not meet study criteria
|
1
|
0
|
|
Follow-Up
Protocol Requires no Follow-Up
|
2
|
1
|
|
Follow-Up
Death
|
1
|
0
|
|
Follow-Up
Other
|
4
|
2
|
|
Follow-Up
Participant Withdrew Consent
|
6
|
1
|
|
Follow-Up
Lost to Follow-up
|
12
|
6
|
Baseline Characteristics
Study Comparing Daclatasvir (BMS-790052) With Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Virus Infection
Baseline characteristics by cohort
| Measure |
Daclatasvir + PEG-IFN Alpha-2a + Ribavirin
n=402 Participants
Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
|
Telaprevir + PEG-IFN Alpha-2a + Ribavirin
n=200 Participants
Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000-1200 mg per day was administered twice daily with food.
|
Total
n=602 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.5 years
STANDARD_DEVIATION 12.12 • n=5 Participants
|
47.6 years
STANDARD_DEVIATION 12.29 • n=7 Participants
|
46.9 years
STANDARD_DEVIATION 12.18 • n=5 Participants
|
|
Age, Customized
Younger than 65 years
|
387 participants
n=5 Participants
|
188 participants
n=7 Participants
|
575 participants
n=5 Participants
|
|
Age, Customized
65 years and older
|
15 participants
n=5 Participants
|
12 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
145 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
226 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
257 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
376 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12 (Follow-up period)Population: The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for SVR12 response.
SVR12 was defined as hepatitis C virus RNA levels to be lower than the limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up Week 12.
Outcome measures
| Measure |
Daclatasvir + PEG-IFN Alpha-2a + Ribavirin
n=268 Participants
Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
|
Telaprevir + PEG-IFN Alpha-2a + Ribavirin
n=134 Participants
Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000-1200 mg per day was administered twice daily with food.
|
|---|---|---|
|
Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
|
85.1 Percentage of participants
Interval 80.2 to 89.1
|
81.3 Percentage of participants
Interval 73.7 to 87.5
|
SECONDARY outcome
Timeframe: Week 4Population: The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for RVR response.
RVR was defined as hepatitis c virus RNA levels lower than lower limit of quantitation, ie, 25 IU/mL target not detected at Week 4 of treatment.
Outcome measures
| Measure |
Daclatasvir + PEG-IFN Alpha-2a + Ribavirin
n=268 Participants
Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
|
Telaprevir + PEG-IFN Alpha-2a + Ribavirin
n=134 Participants
Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000-1200 mg per day was administered twice daily with food.
|
|---|---|---|
|
Percentage of Genotype 1b Participants With Rapid Virologic Response (RVR) at Week 4
|
77.2 Percentage of participants
Interval 71.7 to 82.1
|
79.1 Percentage of participants
Interval 71.2 to 85.6
|
SECONDARY outcome
Timeframe: Week 4, Week 12Population: The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for eRVR response.
eRVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at both Weeks 4 and 12 of treatment.
Outcome measures
| Measure |
Daclatasvir + PEG-IFN Alpha-2a + Ribavirin
n=268 Participants
Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
|
Telaprevir + PEG-IFN Alpha-2a + Ribavirin
n=134 Participants
Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000-1200 mg per day was administered twice daily with food.
|
|---|---|---|
|
Percentage of Genotype 1b Participants With Extended Rapid Virologic Response (eRVR) at Both Week 4 and Week 12
|
75.0 Percentage of participants
Interval 69.4 to 80.1
|
73.1 Percentage of participants
Interval 64.8 to 80.4
|
SECONDARY outcome
Timeframe: Week 12Population: The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for cEVR response.
cEVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at Week 12 of treatment.
Outcome measures
| Measure |
Daclatasvir + PEG-IFN Alpha-2a + Ribavirin
n=268 Participants
Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
|
Telaprevir + PEG-IFN Alpha-2a + Ribavirin
n=134 Participants
Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000-1200 mg per day was administered twice daily with food.
|
|---|---|---|
|
Percentage of Genotype 1b Participants With Complete Early Virologic Response (cEVR)
|
90.7 percentage of participants
Interval 86.5 to 93.9
|
90.03 percentage of participants
Interval 84.0 to 94.7
|
SECONDARY outcome
Timeframe: Week 24 (Follow-up period)Population: The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for SVR24 response.
SVR24 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 24 of treatment.
Outcome measures
| Measure |
Daclatasvir + PEG-IFN Alpha-2a + Ribavirin
n=268 Participants
Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
|
Telaprevir + PEG-IFN Alpha-2a + Ribavirin
n=134 Participants
Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000-1200 mg per day was administered twice daily with food.
|
|---|---|---|
|
Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 24 (SVR24)
|
84.3 Percentage of participants
Interval 79.4 to 88.5
|
80.6 Percentage of participants
Interval 72.9 to 86.9
|
SECONDARY outcome
Timeframe: Week 12 (Follow-up period)Population: The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1a participants assessed for SVR12 response.
SVR12 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 12 of treatment.
Outcome measures
| Measure |
Daclatasvir + PEG-IFN Alpha-2a + Ribavirin
n=134 Participants
Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
|
Telaprevir + PEG-IFN Alpha-2a + Ribavirin
n=66 Participants
Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000-1200 mg per day was administered twice daily with food.
|
|---|---|---|
|
Percentage of Genotype 1a Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
|
64.9 Percentage of participants
Interval 56.2 to 73.0
|
69.7 Percentage of participants
Interval 57.1 to 80.4
|
Adverse Events
Daclatasvir + PEG-IFN Alpha-2a + Ribavirin
Serious events: 26 serious events
Other events: 384 other events
Deaths: 0 deaths
Telaprevir + PEG-IFN Alpha-2a + Ribavirin
Serious events: 20 serious events
Other events: 193 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Daclatasvir + PEG-IFN Alpha-2a + Ribavirin
n=402 participants at risk
Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day)
|
Telaprevir + PEG-IFN Alpha-2a + Ribavirin
n=200 participants at risk
Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000-1200 mg per day was administered twice daily with food
|
|---|---|---|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.25%
1/402
|
0.00%
0/200
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.25%
1/402
|
0.00%
0/200
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.25%
1/402
|
0.00%
0/200
|
|
Injury, poisoning and procedural complications
Overdose
|
0.25%
1/402
|
0.00%
0/200
|
|
Cardiac disorders
Palpitations
|
0.00%
0/402
|
0.50%
1/200
|
|
Infections and infestations
Pneumonia
|
0.75%
3/402
|
0.00%
0/200
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.25%
1/402
|
0.00%
0/200
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/402
|
0.50%
1/200
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.25%
1/402
|
0.00%
0/200
|
|
Gastrointestinal disorders
Duodenitis
|
0.25%
1/402
|
0.00%
0/200
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.25%
1/402
|
0.00%
0/200
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.25%
1/402
|
0.50%
1/200
|
|
Gastrointestinal disorders
Ileus
|
0.25%
1/402
|
0.00%
0/200
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/402
|
0.50%
1/200
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.25%
1/402
|
0.00%
0/200
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.25%
1/402
|
0.00%
0/200
|
|
Infections and infestations
Cellulitis
|
0.50%
2/402
|
0.00%
0/200
|
|
Infections and infestations
Proctitis infectious
|
0.00%
0/402
|
0.50%
1/200
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/402
|
0.50%
1/200
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/402
|
2.5%
5/200
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/402
|
0.50%
1/200
|
|
Infections and infestations
Peritonsillar abscess
|
0.25%
1/402
|
0.00%
0/200
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/402
|
1.0%
2/200
|
|
Infections and infestations
Sepsis
|
0.00%
0/402
|
0.50%
1/200
|
|
Infections and infestations
Bursitis infective
|
0.25%
1/402
|
0.00%
0/200
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.25%
1/402
|
0.00%
0/200
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/402
|
0.50%
1/200
|
|
Injury, poisoning and procedural complications
Concussion
|
0.25%
1/402
|
0.00%
0/200
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.25%
1/402
|
0.50%
1/200
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.25%
1/402
|
0.50%
1/200
|
|
Nervous system disorders
Headache
|
0.00%
0/402
|
0.50%
1/200
|
|
Infections and infestations
Lung infection
|
0.25%
1/402
|
0.00%
0/200
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.25%
1/402
|
0.00%
0/200
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/402
|
0.50%
1/200
|
|
Nervous system disorders
Syncope
|
0.25%
1/402
|
0.50%
1/200
|
|
Psychiatric disorders
Bipolar I disorder
|
0.25%
1/402
|
0.00%
0/200
|
|
Cardiac disorders
Coronary artery disease
|
0.25%
1/402
|
0.00%
0/200
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/402
|
0.50%
1/200
|
|
Psychiatric disorders
Panic attack
|
0.25%
1/402
|
0.00%
0/200
|
|
Infections and infestations
Pneumococcal sepsis
|
0.25%
1/402
|
0.00%
0/200
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/402
|
0.50%
1/200
|
|
Nervous system disorders
Convulsion
|
0.00%
0/402
|
0.50%
1/200
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/402
|
0.50%
1/200
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/402
|
0.50%
1/200
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.25%
1/402
|
0.00%
0/200
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/402
|
0.50%
1/200
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/402
|
0.50%
1/200
|
|
Infections and infestations
Tonsillitis
|
0.25%
1/402
|
0.00%
0/200
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/402
|
0.50%
1/200
|
|
Psychiatric disorders
Depression
|
0.00%
0/402
|
1.0%
2/200
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/402
|
0.50%
1/200
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.25%
1/402
|
0.00%
0/200
|
|
Psychiatric disorders
Panic disorder
|
0.00%
0/402
|
0.50%
1/200
|
Other adverse events
| Measure |
Daclatasvir + PEG-IFN Alpha-2a + Ribavirin
n=402 participants at risk
Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day)
|
Telaprevir + PEG-IFN Alpha-2a + Ribavirin
n=200 participants at risk
Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000-1200 mg per day was administered twice daily with food
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.7%
55/402
|
7.0%
14/200
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.9%
84/402
|
17.0%
34/200
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.9%
48/402
|
12.5%
25/200
|
|
General disorders
Fatigue
|
34.8%
140/402
|
40.5%
81/200
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.2%
61/402
|
11.5%
23/200
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
26.6%
107/402
|
37.5%
75/200
|
|
Nervous system disorders
Disturbance in attention
|
5.5%
22/402
|
5.0%
10/200
|
|
Nervous system disorders
Dizziness
|
8.0%
32/402
|
9.0%
18/200
|
|
Psychiatric disorders
Insomnia
|
17.7%
71/402
|
17.5%
35/200
|
|
General disorders
Pyrexia
|
19.9%
80/402
|
21.0%
42/200
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.1%
93/402
|
34.5%
69/200
|
|
General disorders
Chills
|
7.7%
31/402
|
9.0%
18/200
|
|
Gastrointestinal disorders
Diarrhoea
|
15.7%
63/402
|
17.5%
35/200
|
|
General disorders
Influenza like illness
|
21.1%
85/402
|
19.0%
38/200
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.7%
7/402
|
5.5%
11/200
|
|
Ear and labyrinth disorders
Vertigo
|
4.5%
18/402
|
6.0%
12/200
|
|
Gastrointestinal disorders
Vomiting
|
6.5%
26/402
|
11.5%
23/200
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.0%
24/402
|
7.5%
15/200
|
|
Blood and lymphatic system disorders
Anaemia
|
23.9%
96/402
|
49.0%
98/200
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.75%
3/402
|
9.5%
19/200
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.9%
76/402
|
15.5%
31/200
|
|
Gastrointestinal disorders
Nausea
|
21.9%
88/402
|
37.0%
74/200
|
|
Blood and lymphatic system disorders
Neutropenia
|
21.6%
87/402
|
13.5%
27/200
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.5%
22/402
|
5.5%
11/200
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.7%
19/402
|
7.0%
14/200
|
|
Infections and infestations
Urinary tract infection
|
1.7%
7/402
|
5.0%
10/200
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
21.4%
86/402
|
16.0%
32/200
|
|
Psychiatric disorders
Anxiety
|
2.5%
10/402
|
8.0%
16/200
|
|
Nervous system disorders
Dysgeusia
|
5.7%
23/402
|
10.5%
21/200
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.0%
16/402
|
5.0%
10/200
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.7%
7/402
|
5.5%
11/200
|
|
Nervous system disorders
Headache
|
34.1%
137/402
|
28.5%
57/200
|
|
General disorders
Injection site erythema
|
5.2%
21/402
|
3.5%
7/200
|
|
General disorders
Injection site reaction
|
5.5%
22/402
|
2.5%
5/200
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
27/402
|
7.0%
14/200
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.2%
61/402
|
19.5%
39/200
|
|
Gastrointestinal disorders
Dyspepsia
|
4.2%
17/402
|
8.0%
16/200
|
|
Gastrointestinal disorders
Anal pruritus
|
0.75%
3/402
|
12.5%
25/200
|
|
Psychiatric disorders
Irritability
|
10.7%
43/402
|
13.5%
27/200
|
|
Gastrointestinal disorders
Proctalgia
|
0.50%
2/402
|
5.5%
11/200
|
|
General disorders
Asthenia
|
27.1%
109/402
|
26.5%
53/200
|
|
Psychiatric disorders
Depression
|
7.2%
29/402
|
6.0%
12/200
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER