Trial Outcomes & Findings for Trial of Pembrolizumab Following Weekly Paclitaxel for Platinum-resistant Ovarian, Fallopian Tube or Peritoneal Cancer (NCT NCT03430700)
NCT ID: NCT03430700
Last Updated: 2026-05-20
Results Overview
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), with at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of existing non-target lesions is also considered progression. Using A'Hern's single-stage phase II design with a one-sided 5% significance level and 80% power, ≥16 participants needed to be alive and progression-free at 6 months for the protocol aim to be reached.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
6 months from start of study treatment (maintenance pembrolizumab)
Results posted on
2026-05-20
Participant Flow
Open label, single arm study. Consented and eligible participants were enrolled onto the study to receive study treatment.
All participants met the same protocol eligibility criteria to receive treatment. Prior to enrolment, participants received at least 4 cycles of previous paclitaxel for recurrent ovarian cancer and had a diagnosis of high grade recurrent ovarian/fallopian tube or primary non-mucinous peritoneal cancer, with stable disease.
Participant milestones
| Measure |
Treatment
Maintenance treatment with trial drug pembrolizumab; 200mg IV every 21 days until progression, unacceptable toxicity, patient or clinician decision.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment
n=20 Participants
Maintenance treatment with trial drug pembrolizumab; 200mg IV every 21 days until progression, unacceptable toxicity, patient or clinician decision.
|
|---|---|
|
Age, Customized
Age
|
61 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United Kingdom
|
20 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 6 months from start of study treatment (maintenance pembrolizumab)Population: Patients who received weekly paclitaxel for recurrent ovarian cancer and received at least one cycle of maintenance trial treatment - pembrolizumab.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), with at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of existing non-target lesions is also considered progression. Using A'Hern's single-stage phase II design with a one-sided 5% significance level and 80% power, ≥16 participants needed to be alive and progression-free at 6 months for the protocol aim to be reached.
Outcome measures
| Measure |
Treatment
n=20 Participants
Maintenance treatment with trial drug pembrolizumab; 200mg IV every 21 days until progression, unacceptable toxicity, patient or clinician decision
|
|---|---|
|
Progression-Free Survival Rate at 6 Months From Start of Study Treatment (Maintenance Pembrolizumab)
|
5.0 Percentage of participants
Interval 0.3 to 20.5
|
SECONDARY outcome
Timeframe: 6 months from the start of weekly previously administered standard of care paclitaxel to the date of first progression or death from any cause.Progression Free Survival at 6 months was measured from the start of pre-trial weekly paclitaxel using Kaplan-Meier estimates with censoring on the date of last study assessment.
Outcome measures
| Measure |
Treatment
n=20 Participants
Maintenance treatment with trial drug pembrolizumab; 200mg IV every 21 days until progression, unacceptable toxicity, patient or clinician decision
|
|---|---|
|
Progression Free Survival at 6 Months Measured From the Start of Pre-trial Weekly Paclitaxel
|
95.0 Percentage of participants
Interval 69.5 to 99.3
|
SECONDARY outcome
Timeframe: From start of study treatment until the date of death from any cause or end of study whichever came first, assessed up to 50 months.Kaplan-Meier estimates were used to analyse overall survival from the start of maintenance pembrolizumab to the date of death from any cause.
Outcome measures
| Measure |
Treatment
n=20 Participants
Maintenance treatment with trial drug pembrolizumab; 200mg IV every 21 days until progression, unacceptable toxicity, patient or clinician decision
|
|---|---|
|
Overall Survival
|
10.5 Months
Interval 6.2 to 21.1
|
SECONDARY outcome
Timeframe: Before cycle 1, cycle 4 and cycle 7 of study treatment, then every 12 weekly (4 cycles) during treatment until progression up to 24 months.Disease response as per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1, using CT scan assessment: Complete Response- disappearance of all target lesions; Partial Response at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Progressive Disease - at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (Note: the appearance of one or more new lesions and unequivocal progression is also considered progression); Stable Disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Treatment
n=20 Participants
Maintenance treatment with trial drug pembrolizumab; 200mg IV every 21 days until progression, unacceptable toxicity, patient or clinician decision
|
|---|---|
|
Disease Response
|
5 Percentage of participants
Interval 0.1 to 24.9
|
SECONDARY outcome
Timeframe: Date of first study treatment administration dose until the date of last administration dose of study treatment, assessed for duration of study treatment in all participants: up to 42 months.Population: One participant discontinued treatment due to a treatment-related immune-mediated hepatitis.
The number and percentage of patients who stopped treatment due to any reason other than disease progression were analysed. A median of 3.5 cycles of pembrolizumab were given. Nineteen participants stopped due to disease progression and one participant discontinued due to a treatment related adverse event.
Outcome measures
| Measure |
Treatment
n=20 Participants
Maintenance treatment with trial drug pembrolizumab; 200mg IV every 21 days until progression, unacceptable toxicity, patient or clinician decision
|
|---|---|
|
Treatment Compliance
|
1 Participants
|
Adverse Events
Participants Treated
Serious events: 4 serious events
Other events: 20 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Participants Treated
n=20 participants at risk
Maintenance treatment with trial drug pembrolizumab; 200mg IV every 21 days until progression, unacceptable toxicity, patient or clinician decision.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Infections and infestations
Lung Infection
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.0%
1/20 • Number of events 2 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
Other adverse events
| Measure |
Participants Treated
n=20 participants at risk
Maintenance treatment with trial drug pembrolizumab; 200mg IV every 21 days until progression, unacceptable toxicity, patient or clinician decision.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
5/20 • Number of events 5 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Gastrointestinal disorders
Abdominal cramps
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Psychiatric disorders
Agitation
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Metabolism and nutrition disorders
Anorexia
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
2/20 • Number of events 2 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Gastrointestinal disorders
Bloating
|
10.0%
2/20 • Number of events 2 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Eye disorders
Blurred vision
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Injury, poisoning and procedural complications
Bruising
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Gastrointestinal disorders
Constipation
|
30.0%
6/20 • Number of events 6 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
5/20 • Number of events 6 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Gastrointestinal disorders
Dry Mouth
|
10.0%
2/20 • Number of events 2 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
15.0%
3/20 • Number of events 3 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
4/20 • Number of events 4 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
General disorders
Edema limbs
|
10.0%
2/20 • Number of events 2 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Eye disorders
Itchy eyes
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
General disorders
Fatigue
|
20.0%
4/20 • Number of events 4 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Gastrointestinal disorders
Flatulence
|
10.0%
2/20 • Number of events 2 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Gastrointestinal disorders
Gastroesophageal reflux
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • Number of events 2 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Vascular disorders
Hypertension
|
45.0%
9/20 • Number of events 10 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Endocrine disorders
Hyperthyroidism
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
10.0%
2/20 • Number of events 2 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Endocrine disorders
Hypothyroidism
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Metabolism and nutrition disorders
Increased appetite
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Infections and infestations
Oral Candidiasis
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Infections and infestations
Covid-19
|
10.0%
2/20 • Number of events 2 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.0%
2/20 • Number of events 2 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Gastrointestinal disorders
Mucositis oral
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramp
|
10.0%
2/20 • Number of events 2 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Nervous system disorders
Muscle weakness right-sided
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Gastrointestinal disorders
Nausea
|
30.0%
6/20 • Number of events 6 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Nervous system disorders
Peripheral Neuropathy
|
15.0%
3/20 • Number of events 3 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
General disorders
Pain
|
25.0%
5/20 • Number of events 6 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.0%
1/20 • Number of events 4 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Skin and subcutaneous tissue disorders
Erythema (limbs)
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
General disorders
Edema (hand)
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Infections and infestations
Upper respiratory infection
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
2/20 • Number of events 2 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Renal and urinary disorders
Urinary Urgency
|
10.0%
2/20 • Number of events 3 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Gastrointestinal disorders
Vomiting
|
35.0%
7/20 • Number of events 8 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Investigations
Weight gain
|
5.0%
1/20 • Number of events 1 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
|
Investigations
Weight loss
|
20.0%
4/20 • Number of events 4 • From consent until 30 calendar days (or 16 weeks for adverse events of special interest and serious adverse events) post last treatment administration, assessed one month before first study dose, every 3 weeks during treatment and at 30 days post last treatment administration, up to 30 months. Any serious adverse reactions were assessed every 12 weeks up until participants' last follow-up, up to 32 months. All-Cause Mortality was from first dose until death, assessed up to 50 months.
Adverse experiences were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and characterised in terms of seriousness, causality, severity, and action taken with regard to trial treatment. The number and percentage of participants who experienced a grade 3 or 4 toxicity at any time were analysed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place