Trial Outcomes & Findings for Study of CB-183,315 in Participants With Clostridium Difficile Infection (NCT NCT01085591)
NCT ID: NCT01085591
Last Updated: 2018-09-11
Results Overview
The number of participants with an Investigator-assessed clinical response of cure is presented. The information to assess clinical response was collected at any time up to and including Day 19.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
210 participants
Primary outcome timeframe
Baseline (Day 0) through Study Day 19
Results posted on
2018-09-11
Participant Flow
Participant milestones
| Measure |
CB-183,315, 125 mg
125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
|
CB-183,315, 250 mg
250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days.
|
Oral Vancomycin, 125 mg
125 mg vancomycin administered orally four times a day for 10 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
69
|
71
|
70
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
68
|
69
|
70
|
|
Overall Study
COMPLETED
|
66
|
65
|
63
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
7
|
Reasons for withdrawal
| Measure |
CB-183,315, 125 mg
125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
|
CB-183,315, 250 mg
250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days.
|
Oral Vancomycin, 125 mg
125 mg vancomycin administered orally four times a day for 10 days
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
3
|
|
Overall Study
Physician Decision
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
1
|
|
Overall Study
Other
|
0
|
1
|
0
|
|
Overall Study
Not Properly Consented
|
1
|
0
|
0
|
Baseline Characteristics
Study of CB-183,315 in Participants With Clostridium Difficile Infection
Baseline characteristics by cohort
| Measure |
CB-183,315, 125 mg
n=68 Participants
125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
|
CB-183,315, 250 mg
n=71 Participants
250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days.
|
Oral Vancomycin, 125 mg
n=70 Participants
125 mg vancomycin administered orally four times a day for 10 days
|
Total
n=209 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
LTE18
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
BTWN
|
47 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
130 Participants
n=4 Participants
|
|
Age, Categorical
GTE65
|
21 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
132 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) through Study Day 19Population: All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI).
The number of participants with an Investigator-assessed clinical response of cure is presented. The information to assess clinical response was collected at any time up to and including Day 19.
Outcome measures
| Measure |
CB-183,315, 125mg
n=66 Participants
125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
|
CB-183,315, 250 mg
n=67 Participants
250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
|
Oral Vancomycin, 125 mg
n=66 Participants
125 mg vancomycin administered orally four times a day for 10 days
|
|---|---|---|---|
|
Number of Participants With a Clinical Response Outcome of Clostridium Difficile Infection Cure at the End of Study Treatment
|
61 participants
|
58 participants
|
59 participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) through Study Day 19Population: All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI).
The number of participants with investigator assessed clinical response of failure or unable to evaluate is presented. Clinical response was determined by the participant's condition on the second day following the last dose of study medication, unless considered a treatment failure. Treatment failures were assessed whenever they occurred and were carried forward to the end-of-treatment (EOT). The information to assess clinical response was collected at any time up to and including Day 19.
Outcome measures
| Measure |
CB-183,315, 125mg
n=66 Participants
125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
|
CB-183,315, 250 mg
n=67 Participants
250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
|
Oral Vancomycin, 125 mg
n=66 Participants
125 mg vancomycin administered orally four times a day for 10 days
|
|---|---|---|---|
|
Number of Participants With a Clinical Response Outcome of Failure or Unable to Evaluate at the End of Study Treatment
Failure
|
3 participants
|
5 participants
|
4 participants
|
|
Number of Participants With a Clinical Response Outcome of Failure or Unable to Evaluate at the End of Study Treatment
Unable to Evaluate
|
2 participants
|
4 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Study Day 10 up to Study Day 40Population: All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI).
The number of participants with a recurrence of CDI is presented along with the number of participants without a recurrence and who were unable to be evaluated. Participants with a favorable outcome at the EOT (cure) were evaluated for recurrence of CDI. Only subjects deemed a cure at EOT were assessed for recurrence. This is the denominator used for all percentages. If diarrheal symptoms returned, participants were asked to indicate the number of unformed bowel movements (UBM) they had and have an additional C. difficile toxin test. The information to assess recurrence in participants who were deemed a cure at EOT was collected at any time during the 4-week Follow-up Period (FUP).
Outcome measures
| Measure |
CB-183,315, 125mg
n=61 Participants
125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
|
CB-183,315, 250 mg
n=58 Participants
250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
|
Oral Vancomycin, 125 mg
n=59 Participants
125 mg vancomycin administered orally four times a day for 10 days
|
|---|---|---|---|
|
Number of Participants With a Recurrence of Clostridium Difficile Infection Through the 4-week Follow-up Period
Recurrence of CDI
|
17 Participants
|
10 Participants
|
21 Participants
|
|
Number of Participants With a Recurrence of Clostridium Difficile Infection Through the 4-week Follow-up Period
No Recurrence of CDI
|
44 Participants
|
47 Participants
|
37 Participants
|
|
Number of Participants With a Recurrence of Clostridium Difficile Infection Through the 4-week Follow-up Period
Unable to Evaluate
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0) through Study Day 12Population: All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI).
The number of participants with investigator assessed clinical response of cure, failure or unable to evaluate is presented and shown separately for participants with and without infection caused by C. difficile BI/NAP1/027 strain as determined at baseline. Clinical response was determined by the participant's condition on the second day following the last dose of study medication, unless considered a treatment failure. Treatment failures were assessed whenever they occurred and were carried forward to the EOT. The information to assess clinical response for infection caused by C. difficile BI/NAP1/027 strain at Baseline was collected at any time up to and including Day 12. Strain at Baseline=SAB
Outcome measures
| Measure |
CB-183,315, 125mg
n=66 Participants
125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
|
CB-183,315, 250 mg
n=67 Participants
250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
|
Oral Vancomycin, 125 mg
n=66 Participants
125 mg vancomycin administered orally four times a day for 10 days
|
|---|---|---|---|
|
Number of Participants With a Clinical Response Outcome at the End of Study Treatment With and Without Infection Caused by C. Difficile BI/NAP1/027 Strain at Baseline
Cure of CDI with BI/NAP1/027 SAB (n=18, 21, 23)
|
15 participants
|
15 participants
|
21 participants
|
|
Number of Participants With a Clinical Response Outcome at the End of Study Treatment With and Without Infection Caused by C. Difficile BI/NAP1/027 Strain at Baseline
Failure with SAB (n=18, 21, 23)
|
1 participants
|
4 participants
|
1 participants
|
|
Number of Participants With a Clinical Response Outcome at the End of Study Treatment With and Without Infection Caused by C. Difficile BI/NAP1/027 Strain at Baseline
Unable to Evaluate with SAB (n=18, 21, 23)
|
2 participants
|
2 participants
|
1 participants
|
|
Number of Participants With a Clinical Response Outcome at the End of Study Treatment With and Without Infection Caused by C. Difficile BI/NAP1/027 Strain at Baseline
Cure of CDI without SAB (n=44, 37, 38)
|
42 participants
|
34 participants
|
34 participants
|
|
Number of Participants With a Clinical Response Outcome at the End of Study Treatment With and Without Infection Caused by C. Difficile BI/NAP1/027 Strain at Baseline
Failure without SAB (n=44, 37, 38)
|
2 participants
|
1 participants
|
2 participants
|
|
Number of Participants With a Clinical Response Outcome at the End of Study Treatment With and Without Infection Caused by C. Difficile BI/NAP1/027 Strain at Baseline
Unable to Evaluate without SAB (n=44, 37, 38)
|
0 participants
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Study Day 10 up to Study Day 40Population: All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI).
The number of participants with and without infection caused by C. difficile BI/NAP1/027 strain as determined at baseline with a recurrence of CDI is presented along with the number of participants without a recurrence and who were unable to be evaluated. Participants with a favorable outcome at the EOT (cure) were evaluated for recurrence of CDI. If diarrheal symptoms returned, participants were asked to indicate the number of UBM they had and have an additional C. difficile toxin test. The information to assess recurrence in participants who were deemed a cure at EOT was collected at any time during the 4-week FUP. Strain at Baseline=SAB.
Outcome measures
| Measure |
CB-183,315, 125mg
n=66 Participants
125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
|
CB-183,315, 250 mg
n=67 Participants
250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
|
Oral Vancomycin, 125 mg
n=66 Participants
125 mg vancomycin administered orally four times a day for 10 days
|
|---|---|---|---|
|
Number of Participants With a Recurrence of Clostridium Difficile Infection at the End of Study Treatment With and Without Infection Caused by C. Difficile BI/NAP1/027 Strain at Baseline
Recurrence of CDI with SAB (n=15, 15, 21)
|
5 participants
|
5 participants
|
11 participants
|
|
Number of Participants With a Recurrence of Clostridium Difficile Infection at the End of Study Treatment With and Without Infection Caused by C. Difficile BI/NAP1/027 Strain at Baseline
No Recurrence of CDI with SAB (n=15,15, 21)
|
10 participants
|
9 participants
|
10 participants
|
|
Number of Participants With a Recurrence of Clostridium Difficile Infection at the End of Study Treatment With and Without Infection Caused by C. Difficile BI/NAP1/027 Strain at Baseline
Unable to Evaluate with SAB (n=15,15, 21)
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With a Recurrence of Clostridium Difficile Infection at the End of Study Treatment With and Without Infection Caused by C. Difficile BI/NAP1/027 Strain at Baseline
Recurrence of CDI without SAB (n=42, 34, 34)
|
11 participants
|
5 participants
|
8 participants
|
|
Number of Participants With a Recurrence of Clostridium Difficile Infection at the End of Study Treatment With and Without Infection Caused by C. Difficile BI/NAP1/027 Strain at Baseline
No Recurrence of CDI without SAB (n=42, 34, 34)
|
31 participants
|
29 participants
|
25 participants
|
|
Number of Participants With a Recurrence of Clostridium Difficile Infection at the End of Study Treatment With and Without Infection Caused by C. Difficile BI/NAP1/027 Strain at Baseline
Unable to Evaluate without SAB (n=42, 34, 34)
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0) through Study Day 12Population: All participants who received any amount of study drug, had a confirmed diagnosis of Clostridium difficile infection (CDI), and who achieved resolution of their diarrhea.
The median time to resolution of diarrhea is presented for evaluable participants in each treatment group. The time in days from the start of treatment (time of first dose of study drug) to resolution (time of the last UBM on the day before the first of 2 consecutive days of \< 4 UBMs and sustained through the second day following the last dose of study drug).
Outcome measures
| Measure |
CB-183,315, 125mg
n=58 Participants
125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
|
CB-183,315, 250 mg
n=57 Participants
250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
|
Oral Vancomycin, 125 mg
n=56 Participants
125 mg vancomycin administered orally four times a day for 10 days
|
|---|---|---|---|
|
Median Time to Resolution of Diarrhea
|
1.5 Days
Interval 0.6 to 2.4
|
1.4 Days
Interval 0.9 to 2.3
|
2.1 Days
Interval 1.4 to 2.5
|
Adverse Events
CB-183,315, 125 mg
Serious events: 12 serious events
Other events: 34 other events
Deaths: 0 deaths
CB-183,315, 250 mg
Serious events: 6 serious events
Other events: 43 other events
Deaths: 0 deaths
Oral Vancomycin, 125 mg
Serious events: 11 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CB-183,315, 125 mg
n=68 participants at risk
125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
|
CB-183,315, 250 mg
n=69 participants at risk
250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days.
|
Oral Vancomycin, 125 mg
n=70 participants at risk
125 mg vancomycin administered orally four times a day for 10 days
|
|---|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
1/68 • Number of events 1
|
1.4%
1/69 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
1.4%
1/70 • Number of events 2
|
|
Gastrointestinal disorders
Peritonitis
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
General disorders
Asthenia
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Immune system disorders
Graft versus host disease
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Infections and infestations
Clostridial infection
|
5.9%
4/68 • Number of events 4
|
4.3%
3/69 • Number of events 3
|
5.7%
4/70 • Number of events 4
|
|
Infections and infestations
Cytomegalovirus infection
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Infections and infestations
Endocarditis
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Infections and infestations
Urinary tract infection
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Vascular disorders
Arterial thrombosis
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
Other adverse events
| Measure |
CB-183,315, 125 mg
n=68 participants at risk
125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
|
CB-183,315, 250 mg
n=69 participants at risk
250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days.
|
Oral Vancomycin, 125 mg
n=70 participants at risk
125 mg vancomycin administered orally four times a day for 10 days
|
|---|---|---|---|
|
Eye disorders
Conjunctival discolouration
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Eye disorders
Conjunctival haemorrhage
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Eye disorders
Photophobia
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Eye disorders
Vision blurred
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.5%
1/68 • Number of events 1
|
1.4%
1/69 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
2.9%
2/68 • Number of events 2
|
2.9%
2/69 • Number of events 2
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
4.4%
3/68 • Number of events 3
|
5.8%
4/69 • Number of events 5
|
10.0%
7/70 • Number of events 9
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.9%
2/68 • Number of events 2
|
0.00%
0/69
|
2.9%
2/70 • Number of events 2
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
1.5%
1/68 • Number of events 1
|
1.4%
1/69 • Number of events 1
|
2.9%
2/70 • Number of events 2
|
|
Cardiac disorders
Tachycardia
|
1.5%
1/68 • Number of events 1
|
1.4%
1/69 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
|
Ear and labyrinth disorders
Ear pain
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Ear and labyrinth disorders
Inner ear inflammation
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Ear and labyrinth disorders
Tympanic membrane disorder
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
1.5%
1/68 • Number of events 1
|
2.9%
2/69 • Number of events 2
|
1.4%
1/70 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
4.4%
3/68 • Number of events 3
|
2.9%
2/69 • Number of events 2
|
2.9%
2/70 • Number of events 2
|
|
Gastrointestinal disorders
Dry mouth
|
2.9%
2/68 • Number of events 2
|
0.00%
0/69
|
0.00%
0/70
|
|
Gastrointestinal disorders
Dyspepsia
|
1.5%
1/68 • Number of events 1
|
4.3%
3/69 • Number of events 3
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/68
|
4.3%
3/69 • Number of events 3
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Eructation
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
4.4%
3/68 • Number of events 3
|
2.9%
2/69 • Number of events 2
|
7.1%
5/70 • Number of events 5
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.5%
1/68 • Number of events 1
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Gastrointestinal disorders
Nausea
|
11.8%
8/68 • Number of events 9
|
11.6%
8/69 • Number of events 9
|
5.7%
4/70 • Number of events 5
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
4.4%
3/68 • Number of events 4
|
1.4%
1/69 • Number of events 1
|
2.9%
2/70 • Number of events 3
|
|
General disorders
Asthenia
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
4.3%
3/70 • Number of events 3
|
|
General disorders
Chest discomfort
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
General disorders
Chest pain
|
1.5%
1/68 • Number of events 1
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
General disorders
Chills
|
1.5%
1/68 • Number of events 1
|
1.4%
1/69 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
|
General disorders
Dysplasia
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
General disorders
Fatigue
|
5.9%
4/68 • Number of events 4
|
7.2%
5/69 • Number of events 6
|
5.7%
4/70 • Number of events 4
|
|
General disorders
Feeling abnormal
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
General disorders
Feeling hot
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
General disorders
Hyperthermia
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
General disorders
Inflammation
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
General disorders
Infusion site erythema
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
General disorders
Injection site haematoma
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
General disorders
Oedema
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
General disorders
Oedema peripheral
|
1.5%
1/68 • Number of events 1
|
4.3%
3/69 • Number of events 3
|
2.9%
2/70 • Number of events 3
|
|
General disorders
Pelvic mass
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
General disorders
Pyrexia
|
4.4%
3/68 • Number of events 3
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
General disorders
Tenderness
|
2.9%
2/68 • Number of events 2
|
0.00%
0/69
|
0.00%
0/70
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Infections and infestations
Candidiasis
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Infections and infestations
Candiduria
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Infections and infestations
Gastroenteritis
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Infections and infestations
Hordeolum
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Incision site infection
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Infections and infestations
Injection site infection
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Infections and infestations
Oral candidiasis
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Infections and infestations
Oral herpes
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Infections and infestations
Otitis externa
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Infections and infestations
Pharyngitis
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Infections and infestations
Pneumonia
|
0.00%
0/68
|
0.00%
0/69
|
4.3%
3/70 • Number of events 3
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Infections and infestations
Upper respiratory tract infection
|
1.5%
1/68 • Number of events 1
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Infections and infestations
Urinary tract infection
|
1.5%
1/68 • Number of events 1
|
5.8%
4/69 • Number of events 4
|
5.7%
4/70 • Number of events 4
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Injury, poisoning and procedural complications
Fall
|
2.9%
2/68 • Number of events 3
|
1.4%
1/69 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
|
Injury, poisoning and procedural complications
Head injury
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Injury, poisoning and procedural complications
Joint sprain
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/68
|
2.9%
2/69 • Number of events 2
|
0.00%
0/70
|
|
Investigations
Alanine aminotransferase increased
|
1.5%
1/68 • Number of events 1
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Investigations
Aspartate aminotransferase increased
|
1.5%
1/68 • Number of events 1
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Investigations
Bilirubin conjugated increased
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Investigations
Blood bilirubin unconjugated increased
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Investigations
Blood creatine phosphokinase increased
|
4.4%
3/68 • Number of events 3
|
1.4%
1/69 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
|
Investigations
Blood glucose abnormal
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Investigations
Blood potassium decreased
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Investigations
Blood sodium decreased
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Investigations
Body temperature fluctuation
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Investigations
Eosinophil count increased
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Investigations
Haemoglobin decreased
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Investigations
International normalised ratio increased
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Investigations
Liver function test abnormal
|
2.9%
2/68 • Number of events 2
|
0.00%
0/69
|
0.00%
0/70
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.9%
2/68 • Number of events 2
|
4.3%
3/69 • Number of events 3
|
1.4%
1/70 • Number of events 1
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.9%
2/68 • Number of events 2
|
1.4%
1/69 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Metabolism and nutrition disorders
Increased appetite
|
2.9%
2/68 • Number of events 2
|
0.00%
0/69
|
0.00%
0/70
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
1/68 • Number of events 1
|
1.4%
1/69 • Number of events 1
|
4.3%
3/70 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
1/68 • Number of events 1
|
4.3%
3/69 • Number of events 3
|
0.00%
0/70
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.5%
1/68 • Number of events 1
|
1.4%
1/69 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/68
|
2.9%
2/69 • Number of events 2
|
0.00%
0/70
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
2/68 • Number of events 2
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Nervous system disorders
Carpal tunnel syndrome
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Nervous system disorders
Dizziness
|
2.9%
2/68 • Number of events 2
|
1.4%
1/69 • Number of events 1
|
7.1%
5/70 • Number of events 5
|
|
Nervous system disorders
Dysgeusia
|
1.5%
1/68 • Number of events 1
|
1.4%
1/69 • Number of events 1
|
4.3%
3/70 • Number of events 3
|
|
Nervous system disorders
Headache
|
8.8%
6/68 • Number of events 8
|
11.6%
8/69 • Number of events 14
|
4.3%
3/70 • Number of events 4
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
|
Nervous system disorders
Tremor
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Psychiatric disorders
Agitation
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
|
Psychiatric disorders
Depressed mood
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Psychiatric disorders
Depression
|
1.5%
1/68 • Number of events 1
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Psychiatric disorders
Drug dependence
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Renal and urinary disorders
Oliguria
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Renal and urinary disorders
Urinary incontinence
|
1.5%
1/68 • Number of events 1
|
2.9%
2/69 • Number of events 2
|
0.00%
0/70
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/45
|
0.00%
0/41
|
2.3%
1/44 • Number of events 1
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/45
|
2.4%
1/41 • Number of events 1
|
0.00%
0/44
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
2.2%
1/45 • Number of events 1
|
0.00%
0/41
|
2.3%
1/44 • Number of events 1
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/45
|
2.4%
1/41 • Number of events 1
|
0.00%
0/44
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/68
|
2.9%
2/69 • Number of events 2
|
0.00%
0/70
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.5%
1/68 • Number of events 1
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
1.5%
1/68 • Number of events 1
|
1.4%
1/69 • Number of events 2
|
2.9%
2/70 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/68
|
1.4%
1/69 • Number of events 2
|
1.4%
1/70 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/68
|
0.00%
0/69
|
2.9%
2/70 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/68
|
1.4%
1/69 • Number of events 1
|
0.00%
0/70
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Surgical and medical procedures
Wound drainage
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Vascular disorders
Arterial thrombosis
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Vascular disorders
Embolism
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
|
Vascular disorders
Hot flush
|
0.00%
0/68
|
0.00%
0/69
|
1.4%
1/70 • Number of events 1
|
|
Vascular disorders
Hypotension
|
1.5%
1/68 • Number of events 1
|
0.00%
0/69
|
0.00%
0/70
|
Additional Information
Vice President, Clinical Research
Cubist Pharmaceuticals, Inc.
Phone: 1.781.860.8660
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER