Trial Outcomes & Findings for A Study of Duvelisib in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO) (NCT NCT02391545)
NCT ID: NCT02391545
Last Updated: 2023-09-28
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
55 participants
Primary outcome timeframe
28 days from first dose of study treatment
Results posted on
2023-09-28
Participant Flow
Participant milestones
| Measure |
Duvelisib and Obinutuzumab
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles.
Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
IPI-145 (duvelisib): PI3K Inhibitor
Obinutuzumab
|
Duvelisib and Rituximab
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles.
Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
IPI-145 (duvelisib): PI3K Inhibitor
Rituximab
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
28
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
26
|
28
|
Reasons for withdrawal
| Measure |
Duvelisib and Obinutuzumab
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles.
Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
IPI-145 (duvelisib): PI3K Inhibitor
Obinutuzumab
|
Duvelisib and Rituximab
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles.
Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
IPI-145 (duvelisib): PI3K Inhibitor
Rituximab
|
|---|---|---|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Termination of study by sponsor
|
20
|
20
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Other Reasons
|
6
|
4
|
Baseline Characteristics
A Study of Duvelisib in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)
Baseline characteristics by cohort
| Measure |
Duvelisib and Obinutuzumab
n=27 Participants
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles.
Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
IPI-145 (duvelisib): PI3K Inhibitor
Obinutuzumab
|
Duvelisib and Rituximab
n=28 Participants
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles.
Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
IPI-145 (duvelisib): PI3K Inhibitor
Rituximab
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 12.32 • n=99 Participants
|
58.2 years
STANDARD_DEVIATION 10.65 • n=107 Participants
|
58.3 years
STANDARD_DEVIATION 11.39 • n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Region of Enrollment
Belgium
|
6 participants
n=99 Participants
|
3 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
9 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Region of Enrollment
France
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
4 participants
n=99 Participants
|
9 participants
n=107 Participants
|
13 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 28 days from first dose of study treatmentOutcome measures
| Measure |
Duvelisib and Obinutuzumab
n=27 Participants
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles.
Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
Duvelisib: PI3K Inhibitor
Obinutuzumab
|
Duvelisib and Rituximab
n=28 Participants
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. IPI-145 will be administered orally, twice daily, in 28-day cycles.
Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
Duvelisib: PI3K Inhibitor
Rituximab
|
|---|---|---|
|
Number of Subjects With Dose Limiting Toxicities (DLTs) - Part 1
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 2 years from the first dose of study treatmentOutcome measures
| Measure |
Duvelisib and Obinutuzumab
n=27 Participants
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles.
Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
Duvelisib: PI3K Inhibitor
Obinutuzumab
|
Duvelisib and Rituximab
n=28 Participants
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. IPI-145 will be administered orally, twice daily, in 28-day cycles.
Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
Duvelisib: PI3K Inhibitor
Rituximab
|
|---|---|---|
|
Complete Response Rate (CRR)- Part 2
|
11 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to 30 days after the last dose of study treatmentComposite measure of safety, as indicated by Treatment-emergent adverse events (TEAEs) and changes in safety laboratory values. TEAEs assessed as \>=Grade 3.
Outcome measures
| Measure |
Duvelisib and Obinutuzumab
n=27 Participants
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles.
Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
Duvelisib: PI3K Inhibitor
Obinutuzumab
|
Duvelisib and Rituximab
n=28 Participants
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. IPI-145 will be administered orally, twice daily, in 28-day cycles.
Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
Duvelisib: PI3K Inhibitor
Rituximab
|
|---|---|---|
|
Safety: Composite Measure of Safety, as Indicated by Treatment-emergent Adverse Events (TEAEs) and Changes in Safety Laboratory Values
TEAEs assessed as ≥ Grade 3
|
24 Participants
|
19 Participants
|
|
Safety: Composite Measure of Safety, as Indicated by Treatment-emergent Adverse Events (TEAEs) and Changes in Safety Laboratory Values
TEAEs ≥ Grade 3 assessed as related to duvelisib
|
23 Participants
|
17 Participants
|
|
Safety: Composite Measure of Safety, as Indicated by Treatment-emergent Adverse Events (TEAEs) and Changes in Safety Laboratory Values
TEAEs ≥ Grade 3 assessed as related to anti-CD20
|
11 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 2 years from the first dose of study treatmentOutcome measures
| Measure |
Duvelisib and Obinutuzumab
n=27 Participants
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles.
Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
Duvelisib: PI3K Inhibitor
Obinutuzumab
|
Duvelisib and Rituximab
n=28 Participants
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. IPI-145 will be administered orally, twice daily, in 28-day cycles.
Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
Duvelisib: PI3K Inhibitor
Rituximab
|
|---|---|---|
|
Overall Response Rate (ORR)
Complete Response
|
11 participants
|
10 participants
|
|
Overall Response Rate (ORR)
Partial Response
|
13 participants
|
16 participants
|
|
Overall Response Rate (ORR)
Stable Disease
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 2 years from the first dose of study treatmentPopulation: Data could not be reported because the study was terminated early and a sufficient number of subjects and events were not available for analysis.
The median DOR was non-estimable.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 years from the first dose of study treatmentPopulation: The study had been terminated and Overall Survival was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 4 weeks for 16 weeksPopulation: The study had been terminated and PK analysis was not performed.
Plasma concentrations of Duvelisib and IPI-656 (metabolite)
Outcome measures
Outcome data not reported
Adverse Events
Duvelisib and Obinutuzumab
Serious events: 16 serious events
Other events: 26 other events
Deaths: 0 deaths
Duvelisib and Rituximab
Serious events: 10 serious events
Other events: 27 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Duvelisib and Obinutuzumab
n=27 participants at risk
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles.
Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
IPI-145 (duvelisib): PI3K Inhibitor
Obinutuzumab
|
Duvelisib and Rituximab
n=28 participants at risk
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles.
Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
IPI-145 (duvelisib): PI3K Inhibitor
Rituximab
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
3.7%
1/27 • 35 months
|
0.00%
0/28 • 35 months
|
|
Gastrointestinal disorders
Colitis
|
7.4%
2/27 • 35 months
|
3.6%
1/28 • 35 months
|
|
Gastrointestinal disorders
Diarrhoea
|
7.4%
2/27 • 35 months
|
14.3%
4/28 • 35 months
|
|
Gastrointestinal disorders
Odynophagia
|
3.7%
1/27 • 35 months
|
0.00%
0/28 • 35 months
|
|
Gastrointestinal disorders
Stomatitis
|
3.7%
1/27 • 35 months
|
0.00%
0/28 • 35 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/27 • 35 months
|
3.6%
1/28 • 35 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/27 • 35 months
|
3.6%
1/28 • 35 months
|
|
General disorders
Pyrexia
|
14.8%
4/27 • 35 months
|
7.1%
2/28 • 35 months
|
|
General disorders
Fatigue
|
3.7%
1/27 • 35 months
|
0.00%
0/28 • 35 months
|
|
General disorders
Mucosal Inflammation
|
3.7%
1/27 • 35 months
|
0.00%
0/28 • 35 months
|
|
Hepatobiliary disorders
Hepatotoxicity
|
3.7%
1/27 • 35 months
|
0.00%
0/28 • 35 months
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/27 • 35 months
|
3.6%
1/28 • 35 months
|
|
Infections and infestations
Conjuctivitis
|
3.7%
1/27 • 35 months
|
0.00%
0/28 • 35 months
|
|
Infections and infestations
Diarrhoea infectious
|
3.7%
1/27 • 35 months
|
0.00%
0/28 • 35 months
|
|
Infections and infestations
Klebsiella infection
|
3.7%
1/27 • 35 months
|
0.00%
0/28 • 35 months
|
|
Infections and infestations
Pneumonia
|
3.7%
1/27 • 35 months
|
0.00%
0/28 • 35 months
|
|
Infections and infestations
Pneumonia respiratory synctial viral
|
3.7%
1/27 • 35 months
|
0.00%
0/28 • 35 months
|
|
Infections and infestations
Pylonephritis
|
3.7%
1/27 • 35 months
|
0.00%
0/28 • 35 months
|
|
Infections and infestations
Septic Shock
|
3.7%
1/27 • 35 months
|
0.00%
0/28 • 35 months
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/27 • 35 months
|
3.6%
1/28 • 35 months
|
|
Infections and infestations
Pneumocystis jirovecii infection
|
0.00%
0/27 • 35 months
|
3.6%
1/28 • 35 months
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/27 • 35 months
|
3.6%
1/28 • 35 months
|
|
Infections and infestations
Pneumonia Cytomegaloviral
|
0.00%
0/27 • 35 months
|
3.6%
1/28 • 35 months
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/27 • 35 months
|
3.6%
1/28 • 35 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
3.7%
1/27 • 35 months
|
0.00%
0/28 • 35 months
|
|
Investigations
Alanine aminotransferase increased
|
7.4%
2/27 • 35 months
|
0.00%
0/28 • 35 months
|
|
Investigations
Aspartate aminotransferase increased
|
3.7%
1/27 • 35 months
|
0.00%
0/28 • 35 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/27 • 35 months
|
3.6%
1/28 • 35 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/27 • 35 months
|
3.6%
1/28 • 35 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/27 • 35 months
|
3.6%
1/28 • 35 months
|
|
Nervous system disorders
Syncope
|
3.7%
1/27 • 35 months
|
0.00%
0/28 • 35 months
|
|
Renal and urinary disorders
Renal Failure
|
3.7%
1/27 • 35 months
|
0.00%
0/28 • 35 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.7%
1/27 • 35 months
|
3.6%
1/28 • 35 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.7%
1/27 • 35 months
|
0.00%
0/28 • 35 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.4%
2/27 • 35 months
|
3.6%
1/28 • 35 months
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
3.7%
1/27 • 35 months
|
0.00%
0/28 • 35 months
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/27 • 35 months
|
3.6%
1/28 • 35 months
|
|
Vascular disorders
Embolism
|
0.00%
0/27 • 35 months
|
3.6%
1/28 • 35 months
|
Other adverse events
| Measure |
Duvelisib and Obinutuzumab
n=27 participants at risk
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles.
Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
IPI-145 (duvelisib): PI3K Inhibitor
Obinutuzumab
|
Duvelisib and Rituximab
n=28 participants at risk
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles.
Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
IPI-145 (duvelisib): PI3K Inhibitor
Rituximab
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
18.5%
5/27 • 35 months
|
14.3%
4/28 • 35 months
|
|
Blood and lymphatic system disorders
Anaemia
|
3.7%
1/27 • 35 months
|
7.1%
2/28 • 35 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.7%
1/27 • 35 months
|
7.1%
2/28 • 35 months
|
|
Ear and labyrinth disorders
Vertigo
|
7.4%
2/27 • 35 months
|
0.00%
0/28 • 35 months
|
|
Gastrointestinal disorders
Nausea
|
44.4%
12/27 • 35 months
|
25.0%
7/28 • 35 months
|
|
Gastrointestinal disorders
Diarrhoea
|
40.7%
11/27 • 35 months
|
57.1%
16/28 • 35 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
29.6%
8/27 • 35 months
|
17.9%
5/28 • 35 months
|
|
Gastrointestinal disorders
Vomiting
|
29.6%
8/27 • 35 months
|
10.7%
3/28 • 35 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
18.5%
5/27 • 35 months
|
7.1%
2/28 • 35 months
|
|
Gastrointestinal disorders
Constipation
|
14.8%
4/27 • 35 months
|
17.9%
5/28 • 35 months
|
|
Gastrointestinal disorders
Stomatitis
|
14.8%
4/27 • 35 months
|
3.6%
1/28 • 35 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
11.1%
3/27 • 35 months
|
10.7%
3/28 • 35 months
|
|
Gastrointestinal disorders
Dyspepsia
|
7.4%
2/27 • 35 months
|
0.00%
0/28 • 35 months
|
|
Gastrointestinal disorders
Toothache
|
7.4%
2/27 • 35 months
|
0.00%
0/28 • 35 months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/27 • 35 months
|
7.1%
2/28 • 35 months
|
|
General disorders
Fatigue
|
29.6%
8/27 • 35 months
|
32.1%
9/28 • 35 months
|
|
General disorders
Pyrexia
|
29.6%
8/27 • 35 months
|
21.4%
6/28 • 35 months
|
|
General disorders
Asthenia
|
14.8%
4/27 • 35 months
|
17.9%
5/28 • 35 months
|
|
General disorders
Malaise
|
14.8%
4/27 • 35 months
|
3.6%
1/28 • 35 months
|
|
General disorders
Mucosal Inflammation
|
7.4%
2/27 • 35 months
|
10.7%
3/28 • 35 months
|
|
General disorders
Chills
|
3.7%
1/27 • 35 months
|
7.1%
2/28 • 35 months
|
|
Immune system disorders
Drug Hypersensitivity
|
7.4%
2/27 • 35 months
|
0.00%
0/28 • 35 months
|
|
Infections and infestations
Nasopharyngitis
|
22.2%
6/27 • 35 months
|
3.6%
1/28 • 35 months
|
|
Infections and infestations
Conjuctivitis
|
14.8%
4/27 • 35 months
|
3.6%
1/28 • 35 months
|
|
Infections and infestations
Sinusitis
|
7.4%
2/27 • 35 months
|
3.6%
1/28 • 35 months
|
|
Infections and infestations
Upper respiratory tract infection
|
7.4%
2/27 • 35 months
|
7.1%
2/28 • 35 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
11.1%
3/27 • 35 months
|
3.6%
1/28 • 35 months
|
|
Investigations
Alanine aminotransferase increased
|
48.1%
13/27 • 35 months
|
32.1%
9/28 • 35 months
|
|
Investigations
Aspartate aminotransferase increased
|
48.1%
13/27 • 35 months
|
28.6%
8/28 • 35 months
|
|
Investigations
Amylase increased
|
11.1%
3/27 • 35 months
|
10.7%
3/28 • 35 months
|
|
Investigations
Lipase increased
|
11.1%
3/27 • 35 months
|
10.7%
3/28 • 35 months
|
|
Investigations
Transaminases increased
|
3.7%
1/27 • 35 months
|
10.7%
3/28 • 35 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.2%
6/27 • 35 months
|
0.00%
0/28 • 35 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.1%
3/27 • 35 months
|
3.6%
1/28 • 35 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.4%
2/27 • 35 months
|
0.00%
0/28 • 35 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.4%
2/27 • 35 months
|
0.00%
0/28 • 35 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
3/27 • 35 months
|
21.4%
6/28 • 35 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.4%
2/27 • 35 months
|
3.6%
1/28 • 35 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.4%
2/27 • 35 months
|
0.00%
0/28 • 35 months
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/27 • 35 months
|
7.1%
2/28 • 35 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/27 • 35 months
|
7.1%
2/28 • 35 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/27 • 35 months
|
10.7%
3/28 • 35 months
|
|
Nervous system disorders
Dysgeusia
|
14.8%
4/27 • 35 months
|
3.6%
1/28 • 35 months
|
|
Nervous system disorders
Headache
|
14.8%
4/27 • 35 months
|
14.3%
4/28 • 35 months
|
|
Nervous system disorders
Dizziness
|
7.4%
2/27 • 35 months
|
3.6%
1/28 • 35 months
|
|
Psychiatric disorders
Anxiety
|
11.1%
3/27 • 35 months
|
17.9%
5/28 • 35 months
|
|
Psychiatric disorders
Depression
|
7.4%
2/27 • 35 months
|
3.6%
1/28 • 35 months
|
|
Psychiatric disorders
Insomnia
|
3.7%
1/27 • 35 months
|
7.1%
2/28 • 35 months
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/27 • 35 months
|
7.1%
2/28 • 35 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.2%
6/27 • 35 months
|
25.0%
7/28 • 35 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
14.8%
4/27 • 35 months
|
7.1%
2/28 • 35 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.4%
2/27 • 35 months
|
14.3%
4/28 • 35 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.4%
2/27 • 35 months
|
0.00%
0/28 • 35 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
3.7%
1/27 • 35 months
|
7.1%
2/28 • 35 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.9%
7/27 • 35 months
|
25.0%
7/28 • 35 months
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
11.1%
3/27 • 35 months
|
7.1%
2/28 • 35 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.4%
2/27 • 35 months
|
3.6%
1/28 • 35 months
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
7.4%
2/27 • 35 months
|
3.6%
1/28 • 35 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.7%
1/27 • 35 months
|
7.1%
2/28 • 35 months
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
3.7%
1/27 • 35 months
|
10.7%
3/28 • 35 months
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/27 • 35 months
|
7.1%
2/28 • 35 months
|
|
Vascular disorders
Orthostatic Hypotension
|
3.7%
1/27 • 35 months
|
7.1%
2/28 • 35 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/27 • 35 months
|
10.7%
3/28 • 35 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place