Trial Outcomes & Findings for Study of Cetuximab in Combination With Chemotherapy in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) (NCT NCT00971932)
NCT ID: NCT00971932
Last Updated: 2014-04-08
Results Overview
Percentage of participants experiencing a complete response \[CR\] (complete disappearance of measurable and evaluable disease without new lesions) or partial response \[PR\] (greater than or equal to 50 percent decrease in the sum of the products of diameters \[SOPD\] of index lesions compared to the baseline SOPD, with no evidence of PD) confirmed by a subsequent assessment no less than 28 days after criteria for response were first met based on modified WHO criteria as assessed by Independent Review Committee (IRC).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
Evaluations performed every 6 weeks until progressive disease (PD) reported between day of first participant treated, until cut-off date, 02 March 2011
Results posted on
2014-04-08
Participant Flow
Participant milestones
| Measure |
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)
Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m\^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m\^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m\^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m\^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 \[AUC5\]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)
Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m\^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m\^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m\^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m\^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 \[AUC5\]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Investigator's decision
|
2
|
|
Overall Study
Ongoing
|
4
|
Baseline Characteristics
Study of Cetuximab in Combination With Chemotherapy in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Baseline characteristics by cohort
| Measure |
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)
n=33 Participants
Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m\^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m\^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m\^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m\^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 \[AUC5\]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
|
|---|---|
|
Age, Continuous
|
57.20 years
STANDARD_DEVIATION 11.42 • n=93 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Evaluations performed every 6 weeks until progressive disease (PD) reported between day of first participant treated, until cut-off date, 02 March 2011Population: Intention-to-treat (ITT) population included all participants who received at least one dose of the study medication.
Percentage of participants experiencing a complete response \[CR\] (complete disappearance of measurable and evaluable disease without new lesions) or partial response \[PR\] (greater than or equal to 50 percent decrease in the sum of the products of diameters \[SOPD\] of index lesions compared to the baseline SOPD, with no evidence of PD) confirmed by a subsequent assessment no less than 28 days after criteria for response were first met based on modified WHO criteria as assessed by Independent Review Committee (IRC).
Outcome measures
| Measure |
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)
n=33 Participants
Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m\^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m\^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m\^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m\^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 \[AUC5\]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
|
|---|---|
|
Best Overall Response (BOR) According to Modified World Health Organization (WHO) Criteria
|
36.4 percentage of participants
Interval 20.4 to 54.9
|
SECONDARY outcome
Timeframe: Evaluations performed every 6 weeks until PD reported between day of first participant treated, until cut-off date, 02 March 2011Population: ITT population included all participants who received at least one dose of the study medication.
Percentage of participants with objective response based assessment of confirmed CR or confirmed PR according to RECIST as assessed by IRC. CR are those that persist on repeat imaging study at least 28 days after initial documentation of response. PR are those with greater than or equal to 30 percent decrease in the SOPD of index lesions compared to the baseline SOPD, with no evidence of PD.
Outcome measures
| Measure |
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)
n=33 Participants
Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m\^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m\^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m\^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m\^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 \[AUC5\]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
|
|---|---|
|
Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
|
45.5 percentage of participants
Interval 28.1 to 63.6
|
SECONDARY outcome
Timeframe: Evaluations performed every 6 weeks until PD reported between day of first participant treated, until cut-off date, 02 March 2011Population: ITT population included all participants who received at least one dose of the study medication.
Percentage of participants experiencing a CR (complete disappearance of measurable and evaluable disease without new lesions) or PR (\>=50 percent decrease in sum of the products of diameters \[SOPD\] of index lesions compared to baseline SOPD, with no evidence of PD) confirmed by subsequent assessment no less than 28 days after criteria for response were first met) or stable disease \[SD\] (neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD) at least once no less than 42 days after first dose of trial treatment based on modified WHO criteria as assessed by IRC.
Outcome measures
| Measure |
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)
n=33 Participants
Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m\^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m\^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m\^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m\^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 \[AUC5\]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
|
|---|---|
|
Disease Control Rate
|
87.9 percentage of participants
Interval 71.8 to 96.6
|
SECONDARY outcome
Timeframe: Time from first assessment of CR or PR to PD, death or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011Population: Subgroup of participants from the study population with a best overall response (CR or PR).
Duration of response according to modified WHO criteria as assessed by IRC was defined as the time from the first assessment of CR or PR until the date of the first occurrence of PD, or until the date of death when death occurred within 60 days of the last tumor assessment or first administration of trial treatment (whichever was last).
Outcome measures
| Measure |
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)
n=12 Participants
Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m\^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m\^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m\^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m\^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 \[AUC5\]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
|
|---|---|
|
Duration of Response
|
2.8 months
Interval 2.8 to 5.5
|
SECONDARY outcome
Timeframe: Time from first administration of trial treatment to PD, death or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011Population: ITT population included all participants who received at least one dose of the study medication.
The PFS time according to modified WHO criteria as assessed by IRC was defined as duration from first administration of trial treatment until PD (radiological or clinical, if radiological progression is not available) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment.
Outcome measures
| Measure |
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)
n=33 Participants
Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m\^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m\^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m\^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m\^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 \[AUC5\]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
|
|---|---|
|
Progression-Free Survival (PFS) Time
|
4.1 months
Interval 4.0 to 5.5
|
SECONDARY outcome
Timeframe: Time from first administration of trial treatment or last day known to be alive, reported between day of first participant treated, until cut-off date, 02 March 2011Population: ITT population included all participants who received at least one dose of the study medication.
Time from first administration of trial treatment to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
Outcome measures
| Measure |
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)
n=33 Participants
Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m\^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m\^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m\^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m\^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 \[AUC5\]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
|
|---|---|
|
Overall Survival (OS) Time
|
12.8 months
Interval 8.7 to
The upper limit of confidence interval (CI) for the median OS time was not estimated because no further events occurred after estimated median survival time of 12.8 months.
|
SECONDARY outcome
Timeframe: Time from first administration of trial treatment to treatment failure or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011Population: ITT population included all participants who received at least one dose of the study medication. Here number of participants analyzed "N" is signifying those participants for whom trial treatment failed.
Time to treatment failure according to modified WHO criteria as assessed by IRC was defined as the time from first administration of trial treatment until the date of the first occurrence of one of the events defining treatment failure: PD assessed by the investigator, discontinuation of treatment due to PD, discontinuation of treatment due to an adverse event (AE), start of any new anticancer therapy, or withdrawal of consent or death within 60 days of the last tumor assessment or first administration of trial treatment.
Outcome measures
| Measure |
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)
n=29 Participants
Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m\^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m\^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m\^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m\^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 \[AUC5\]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
|
|---|---|
|
Time to Treatment Failure
|
4.2 months
Interval 4.1 to 5.6
|
Adverse Events
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)
Serious events: 12 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)
n=33 participants at risk
Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m\^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m\^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m\^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m\^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 \[AUC5\]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
|
|---|---|
|
Cardiac disorders
Intracardiac mass
|
3.0%
1/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Diarrhea
|
3.0%
1/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Dysphagia
|
3.0%
1/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Mechanical ileus
|
3.0%
1/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Esophageal fistula
|
3.0%
1/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Septic shock
|
3.0%
1/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Staphylococcal sepsis
|
3.0%
1/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
C-reactive protein increased
|
3.0%
1/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.0%
1/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.0%
1/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hypercreatininemia
|
3.0%
1/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
3.0%
1/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Headache
|
3.0%
1/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Syncope
|
3.0%
1/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
Other adverse events
| Measure |
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)
n=33 participants at risk
Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m\^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m\^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m\^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m\^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 \[AUC5\]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
84.8%
28/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Blood and lymphatic system disorders
Neutropenia
|
81.8%
27/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
60.6%
20/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Blood and lymphatic system disorders
Anemia
|
48.5%
16/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
33.3%
11/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
12.1%
4/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
6.1%
2/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
69.7%
23/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Acne
|
63.6%
21/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
60.6%
20/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
30.3%
10/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
21.2%
7/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Rash generalized
|
15.2%
5/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalized
|
15.2%
5/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
15.2%
5/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Skin chapped
|
12.1%
4/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.1%
4/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
6.1%
2/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Stomatitis
|
78.8%
26/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Nausea
|
69.7%
23/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
22/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Diarrhea
|
48.5%
16/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Vomiting
|
36.4%
12/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Cheilitis
|
27.3%
9/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Abdominal distension
|
9.1%
3/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.1%
3/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Dysphagia
|
9.1%
3/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.1%
2/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.1%
2/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
6.1%
2/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
90.9%
30/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
81.8%
27/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
42.4%
14/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
30.3%
10/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
24.2%
8/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hypochloremia
|
18.2%
6/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
18.2%
6/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
15.2%
5/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Metabolism and nutrition disorders
Hypercreatininemia
|
15.2%
5/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Fatigue
|
57.6%
19/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Malaise
|
21.2%
7/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Injection site extravasation
|
6.1%
2/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Mucosal inflammation
|
6.1%
2/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Face edema
|
6.1%
2/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Chills
|
6.1%
2/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Infusion related reaction
|
6.1%
2/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Injection site swelling
|
6.1%
2/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Non-cardiac chest pain
|
6.1%
2/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Pyrexia
|
21.2%
7/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Weight decreased
|
48.5%
16/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Hemoglobin decreased
|
27.3%
9/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Blood albumin decreased
|
18.2%
6/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Blood alkaline phosphatase increased
|
18.2%
6/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Protein total decreased
|
18.2%
6/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Weight increased
|
15.2%
5/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Blood lactate dehydrogenase increased
|
9.1%
3/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Blood creatinine increased
|
9.1%
3/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Alanine aminotransferase increased
|
9.1%
3/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.1%
2/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Blood urea increased
|
6.1%
2/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Paronychia
|
57.6%
19/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Nasopharyngitis
|
9.1%
3/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
39.4%
13/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
24.2%
8/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
6.1%
2/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.1%
2/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.1%
2/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
11/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Headache
|
15.2%
5/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Neuropathy peripheral
|
12.1%
4/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Syncope
|
6.1%
2/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
24.2%
8/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Cardiac disorders
Ventricular extrasystoles
|
6.1%
2/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.1%
4/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Renal and urinary disorders
Nephropathy toxic
|
9.1%
3/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Renal and urinary disorders
Renal impairment
|
6.1%
2/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Psychiatric disorders
Insomnia
|
18.2%
6/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Psychiatric disorders
Anxiety
|
6.1%
2/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Fall
|
6.1%
2/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Eye disorders
Ocular hyperemia
|
6.1%
2/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Vascular disorders
Orthostatic hypotension
|
15.2%
5/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
|
Ear and labyrinth disorders
Tinnitus
|
15.2%
5/33 • Baseline until 30 days after last trial treatment.
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP regardless of causal relationship and even if no IMP has been administered.
|
Additional Information
Merck KGaA Communication Center
Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER